Surgipro II - Monofilament Polypropylene - Covidien LP

Duns Number:058614483

Device Description: Monofilament Polypropylene

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More Product Details

Catalog Number

-

Brand Name

Surgipro II

Version/Model Number

VP558X-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K010909,K010909

Product Code Details

Product Code

GAW

Product Code Name

Suture, nonabsorbable, synthetic, polypropylene

Device Record Status

Public Device Record Key

846f373f-6b39-4e4d-b336-3d6aaf4c1592

Public Version Date

February 15, 2022

Public Version Number

3

DI Record Publish Date

January 30, 2020

Additional Identifiers

Package DI Number

20884521758695

Quantity per Package

36

Contains DI Package

10884521758698

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"COVIDIEN LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 132
2 A medical device with a moderate to high risk that requires special controls. 8540
3 A medical device with high risk that requires premarket approval 202
U Unclassified 40